Kornimate/medical-research-clean huggingface dataset:
guided self-help for anxiety - a patient preference trial

Conditions: Anxiety

Summary: supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. in improving access to psychological therapies (iapt) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (gsh), when they are deemed suitable for treatment at step 2 of iapt services (termed cbt-gsh). step 2 interventions are guided self-help (gsh) delivered by psychological wellbeing practitioners (pwps). recently, a new type of gsh has been developed and found to be feasible and effective in iapt services - this is called cognitive-analytic guided self-help (cat-gsh). this research aims to test the efficacy of cat-gsh by comparing outcomes over time achieved in both types of gsh and interviewing participants about their experience of the gsh. the methodology to support patient choice is a patient preference trial. in this method, then patients that meet inclusion criteria for the trial are offered and choose between either cat-gsh and cbt-gsh. those patients that are unconcerned with the type of treatment are randomised to either cat-gsh or cbt-gsh. the primary outcome measure is the beck anxiety inventory. no changes to the standard practice of the pwps will occur during the trial, the trial will be situated in a standard iapt service and be a therefore conducted in a routine practice setting.


Eligibility criteria:
inclusion criteria: * patients have self-referred or been referred by their gp or other health or social care professional for a step 2 intervention for treatment of a common mental health problem, * patients meet criteria for an anxiety disorder on mini screening interview assessment and also met caseness on the bai (as defined by a score of \>10 on the bai at assessment). * patients want to engage in gsh to address the anxiety disorder * patients are motivated to engage in treatment and can attend six sessions of face-to-face gsh. exclusion criteria: * engaging in any another iapt step 2 interventions. * do not meet criteria for an anxiety disorder as defined by the mini and the bai score. * meet criteria for depression and a comorbid anxiety disorder, as identified by the bai and mini, where the depression is more severe and is the patient's main concern. * have a severe/chronic mental health problem and are already involved in psychiatric or secondary care mental health services. * have substance misuse issues that would interfere with engagement with the gsh. * have a diagnosed learning disability that precludes engagement in gsh. * have a diagnosis of social phobia or ptsd

Keywords: guided self help cognitive analytic therapy cognitive behavioral therapy
incidence and nature of heparin-induced skin lesions in medical patients

Conditions: Allergy

Summary: an increased number of patients with heparin-induced skin lesions is reported in the literature. heparin-induced skin lesions may result from either occlusion of cutaneous vessels in patients suffering from autoimmune hit or from a type iv allergic reaction (delayed type hypersensitivity (dth) response). however, the incidence and nature of heparin-induced skin lesions has not been determined in a prospective investigation. to address this open issue is the goal of this ongoing, so far monocenter, clinical investigation.


Eligibility criteria:
inclusion criteria: * age \> 18 y. * s.c. anticoagulant therapy \>6 days exclusion criteria: * history of hit * history of dth to heparin

Keywords: heparin heparin-induced thrombocytopenia hit allergy skin dermatology dth delayed-type hypersensitivity histology patients receiving sc heparin therapy age over 18 years recruitment will stop when 20 patients with skin lesions are included
adipokines of epicardial adipose tissue and atherosclerosis of coronary arteries

Conditions: Coronary Atherosclerosis; Adipokines

Summary: the aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis.

the aim of the study is to investigate whether the expression and production of four adipokines \[adiponectin, omenin-1, resistin and retinol binding protein-4 (rbp4)\] secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. specifically, this study aims to investigate whether the expression and production of these adipokines is different between two sites of the heart, that are perfused by coronary arteries with different degrees of stenosis.

Eligibility criteria:
inclusion criteria: 1) individuals undergoing cardiac surgery exclusion criteria: * age \< 18 years * hba1c \> 7.0% * any change of antidiabetic medication the previous 3 months before the surgery * gfr \< 60 ml/min/1.73 m2 * liver disease * cancer * non-treated hyperthyroidism or hypothyroidism * autoimmune disease * infection * any change in body weight at least 5% the previous 3 months before surgery * significant dehydration. * taking any of the following drugs the previous 3 months before surgery: hormones, antiobesity drugs

Keywords: adiponectin omentin-1 resistin rbp4 epicardial fat coronary artery disease
the sleep-pain relationship in women with endometriosis

Conditions: Endometriosis

Summary: the goal of this study is to examine the sleep-pain relationship in women diagnosed with endometriosis, by monitoring different symptoms of endometriosis and sleep through an experience sample method study (esm).the main question it aims to answer is: how does sleep impact cyclic and chronic pain and vice versa in women with endometriosis? participants will be asked to fill in a 6-item diary (twice a day) over the course of 2 months.


Eligibility criteria:
inclusion criteria: * adult premenopausal women with a laparoscopic and histopathological diagnosis of endometriosis, without a history of hysterectomy, experiencing cyclic or chronic pelvic pain for 3 months or longer, with pain intensity of at least 3 out of 10 over the past 3 months, experiencing non-restorative sleep (defined as a subjective feeling of being unrefreshed up-on awakening) for 3 months or longer, in the absence of elevated risk for intrinsic sleep disorders (such as sleep apnea or restless leg syndrome), and having sufficient knowledge of either french, dutch, or english exclusion criteria: * participants younger than 18 years old, without laparoscopic and histopathological diagnosis of endometriosis, participants with a hysterectomy or pain intensity lower than 3/10, with restorative sleep or sleep apnea and restless leg syndrome, shift work and insufficient knowledge of either french, dutch or english.

Keywords: esm endometriosis sleep cyclic pain chronic pelvic pain
first-line chemotherapy and panitumumab in advanced non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced non small cell lung cancer improves the treatment outcome. patients are selected based on triple mutational status.

advanced nsclc holds a very poor prognosis with a moderate response rate to standard chemotherapy. the standard first-line treatment for advanced nsclc is platinum based combination chemotherapy. the response rates are less than 30% and a substantial amount of patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting, neuropathies or a considerable risk of renal toxicity. the median progression free survival is 3-4 months and consequently, the median overall survival is less than one year (hotta et al 2007). addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic (stage iv) nsclc * measurable disease according to recist v.1.0 2009 * kras, braf and pi3k wild type in primary tumor or metastatic tissue. * age ≥18 * ps \< 2 * adequate organ function haematology: * neutrophil count ≥1.5x10\^9/l * platelet count ≥100x10\^9/l * leucocyte count \> 3,000/mm hepatic function: * total bilirubin ≤ 1.5 times the upper normal limit (unl) * serum transaminases ≤ 2.5xunl in absence of liver metastases, or ≤ 5xunl in presence of liver metastases renal function: * creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5xunl metabolic function: * magnesium ≥ lower limit of normal. * calcium ≥ lower limit of normal. consent to translational research studies written informed consent exclusion criteria: * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease. * known cns metastasis (pretreatment routine assessment not required) * prior chemotherapy for metastatic disease * indication for radiation therapy or prior radiotherapy within 30 days before treatment start. * other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ. * other experimental therapy within 30 days prior to treatment initiation. * history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan. * patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. * patients (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.

Keywords: lung cancer non small cell lung cancer triple mutational status kras braf pi3k
apl93: timing of cxt and role of maintenance

Conditions: Leukemia, Promyelocytic, Acute

Summary: objectives of the trial were to assess the optimal timing of chemotherapy with or after atra and the role of maintenance therapy.

induction treatment was stratified by age and initial wbc count. patients ≤65 years of age with a wbc count less than 5,000/µl were randomized to receive the reference atra treatment of our previous trial (apl91 trial) {fenaux, 1993 #2088}, ie, 45 mg/m2/d atra followed by ct (atra→ct group) or atra plus ct (atra+ct). in the atra→ct group, patients received 45 mg/m2/d atra orally until cr, with a maximum of 90 days. after cr achievement, they received a course of 60 mg/m2/d daunorubicin (dnr) for 3 days and 200 mg/m2/d arac for 7 days (course i). however, course i was added to atra if the wbc count was increased to greater than 6,000/µl, 10,000/µl, or 15,000/µl by day 5, 10, and 15 of atra treatment, respectively, be-cause, from our experience, patients were at risk of atra syndrome above those thresholds{de botton, 2003 #1127; de botton, 1998 #1604}. patients randomized to the atra+ct group received the same combination of atra and ct, with course i of ct starting on day 3 of atra treatment. patients with a wbc count greater than 5,000/µl at presentation (irrespective of their age) and patients 66 to 75 years of age with a wbc count ≤ 5,000/µl were not ran-domized but received atra plus ct course i from day 1 (high wbc group) and the same schedule as in the atra→ct group (elderly group), respectively. treatment of coagulopathy during the induction phase was based on platelet support to maintain the platelet count at a level greater than 50,000 /µl until the disappea-rance of coagulopathy. the use of heparin, tranexamic acid, fresh frozen plasma, and fibrinogen transfusions was optional. cr patients received 2 ct consolidation courses, including course ii (identical to course i) and course iii, consisting of 45 mg/m2/d dnr for 3 days and 1 g/m2 arac every 12 hours for 4 days. the elderly group only received course ii. three to 4 weeks after hematological recovery from this consolidation ct, patients who were still in cr were randomized both to receive or not receive intermittent atra (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous ct with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, oral-ly), according to a 2-by-2 factorial design stratified on the initial induction treatment group. maintenance treatment was scheduled for 2 years. randomizations for induc-tion and maintenance, stratified on center, were performed through a centralized tele-phone assignment procedure.

Eligibility criteria:
inclusion criteria: 1. diagnosis of apl, based on morphology criteria 2. age 75 years or less; and 3. written informed consent. diagnosis had to be subsequently confirmed by presence of t(15;17) or pml-rar gene rearrangement. in the absence of t(15;17) and if no analysis of the rearrangement could be made, review of initial marrow slides by an independent morphologist was mandatory.

Keywords: apl
adolescent depression screening and treatment in mozambican primary care

Conditions: Depression; Adolescent Behavior

Summary: this is a cluster-randomized pilot trial of depression screening and treatment implementation at four youth-friendly health services (yfhs) in primary care clinics, two in maputo city and two in maputo province. yfhs will be stratified by urbanicity, such that one yfhs in maputo city and one yfhs in maputo province will be randomized to interpersonal psychotherapy (ipt)-a and the other yfhs in each location with be randomized to treatment as usual (tau).

mental disorders are the leading cause of disability among adolescents worldwide, but only a very small minority, mostly in high-resource settings, have access to mental health care. the investigators' work is focused on understanding how to increase access to mental health care for adolescents in low-resource settings. in mozambique, where this work is based, there are just 15 psychiatrists and 180 psychologists to serve its population of 29 million. in collaboration with local stakeholders, including governmental policymakers and primary care providers, the investigators developed a plan to implement care for adolescent depression in primary care settings. the investigators now aim to examine changes in adolescent depression and acceptability of primary care-based mental health services compared to treatment as usual.

Eligibility criteria:
inclusion criteria: 1. providers: 1. ipt-ag arm: yfhs staff will be included in the study if they (a) conduct screening for depression and/or group ipt-ag and (b) provide consent to participate in the study. 2. tau arm: yfhs staff will be included in the study if they (a) provide referrals for adolescents suspected of having mental illness or seeking mental health services and (b) provide consent to participate in the study. treatment providers (psychiatric technicians and psychologists) will be included in the study if they (a) treat adolescents referred from participating yfhs for depression and (b) provide consent to participate in the study. 2. patients: in both study arms, adolescents attending one of the four study yfhs will be included in the study if they: 1. are between the ages of 12-19 years; 2. screen positive for depression; 3. provide informed consent (ages 16 -19) or if their guardian provides informed consent and they provide assent (if ages 12-15). 3. study centers: must be clinics that have yfhs. exclusion criteria: in both study arms, adolescents will be excluded if they: 1. are unable to participate in treatment due to acute illness; and/or 2. are unable to communicate sufficiently in portuguese to answer inclusion questions.

Keywords: adolescent depression
orthokeratology and 0.01% atropine sequential treatment for myopia control

Conditions: Myopia

Summary: the purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.

myopia constitutes a major threat to vision health globally for its increasing prevalence and irriversible blinding complications. it is crucial to effectively intervene subjects with progressive myopia to reduce risks of myopic pathologies in later life. orthokeratology (ortho-k) is the first-line intervention for myopia control, with an efficacy of slowing axial elongation by 43-63%. however, the efficacy decreases over time. sequential treatment strategy, which switches myopia control interventions at some intervals, has a potential to increase myopia control efficacy regarding the whole treatment period, compared to applying one intervention throughout. however, there lacks evidence supporting the benefit of this treatment strategy. the purpose of this study is to evaluate the effectiveness of orthokeratology and 0.01% atropine sequential treatment on myopia control in children and adolescents, as compared to continuous treatment with orthokeratology, using a multicenter randomized controlled trial design. subjects will be randomly assigned into either ortho-k and 0.01% atropine sequential treatment group or ortho-k continuous treatment group. their axial length will be monitored over two years. changes in axial length in the two groups will be compared.

Eligibility criteria:
inclusion criteria: 1. aged 8-15 years old. 2. spherical equivalent refractions (sers) -0.50 to -6.00 dioptres (d) and astigmatism less than -1.5 d in both eyes, anisometropia less than 1.5 d. 3. best corrected visual acuity (bcva) equal to or better than 20/25 in both eyes. 4. bilateral intra-ocular pressure \< 21mmhg. 5. normal binocular and stereoscopic visual function. 6. participants and their guardians' understanding and acceptance of random allocation of grouping. exclusion criteria: 1. manifest strabismus, except for intermittent tropia. 2. ocular or systemic diseases which may affect vision or refractive error. 3. previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses. 4. other contraindications.
unexcitability along the ablation as an endpoint for atrial fibrillation ablation

Conditions: Paroxysmal Atrial Fibrillation; Catheter Ablation Strategies

Summary: to assess the near-term (12 months) efficacy of pulmonary vein isolation.

the aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 years * paroxysmal atrial fibrillation exclusion criteria: * structural heart disease * intracardiac thrombus * reversible causes of atrial fibrillation * inability to take warfarin
brain plasticity and glp-1 receptor agonist treatment for obesity

Conditions: Obesity/Therapy

Summary: glucagon-like peptide 1 receptor agonists (glp-1ra), such as ozempic and wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. however, despite this rapid adoption and the known glp-1ra mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. the goal of the current study is to compare youth and adults with obesity who are treated a glp-1ra and measure potential difference in glp-1ra associated change in brain function, appetite, and eating behaviors.


Eligibility criteria:
inclusion criteria: * english-speaking * male or female (sex assigned at birth) * 12-18 y/o with obesity (bmi\>120% of the 95th %ile) * 30-45 y/o with obesity (bmi\>35 kg/m2) exclusion criteria: * treated with glucagon-like peptide-1 (glp-1) agonists (e.g., exenatide, liraglutide, semaglutide, tirzepatide) for weight management in the prior 3 months * currently taking anti-psychotic medications (anti-depressants accepted) * diagnosis of type 2 diabetes * current or lifetime anorexia nervosa or current bulimia nervosa * head injury resulting in loss of consciousness \>30min * neurological disorder (e.g., parkinson's disease) or history of stroke * any contraindication to receiving a mri (e.g., orthodontal braces) * psychological/behavioral dysfunction (e.g., autism spectrum disorder) or physical impairment that would interfere with study procedures, as determined by study physician * if female, desiring to become pregnant, or currently pregnant or breastfeeding

Keywords: adolescent adult brain function glucagon-like peptide-1 receptor agonists eating behaviors appetite sensations
medical marijuana and open road driving task

Conditions: Medical Cannabis

Summary: medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. to date, no studies systematically assess driving performance in a rigorous and ecologically valid manner accounting for long-term medical marijuana use and/or the combined effect of prescription opioid use in adults 50 and older who endorse chronic or severe non-malignant pain. further, studies examining how older adults self-regulate prescription medication use and driving behavior is limited, with none rigorously examining medical marijuana.


Eligibility criteria:
inclusion criteria: * age 50 and older who endorse chronic or severe non-malignant pain * resident of florida with an active and valid florida drivers license * can communicate in english * willing and able to complete study procedures * have active medical marijuana card for \>12 months issued by the state of florida (mmg group) or are race-sex match who has not used marijuana in the past 10 years with no history of daily use (nmg group) exclusion criteria: * have active psychosis * have lost or revoked driving privileges * score of below the cut 24 (out of 30) on the montreal cognitive assessment (moca) * are a control participant who urine test positive for marijuana use and/or reports any marijuana use in past 10 years
long term effects of awake prone positioning in covid-19 icu patients

Conditions: SARS-CoV 2 Pneumonia

Summary: long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering sars-cov2 pneumonia (nct04358939)

all patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.

Eligibility criteria:
inclusion criteria: * patients included in the randomized meta-trial evaluating awake prone position versus control among covid-19 patients on high-flow nasal oxygen therapy (ehrmann 2021). * patients alive at d28 * no opposition to participate in the research which evaluates mortality and quality of life by telephone interview. exclusion criteria: * patients lost to follow-up after 28 days. * withdrawal of consent from randomized meta-trial by patient * vulnerable person: safeguard of justice, curatorship, or guardianship * patients refusing to answer telephone questionnaire.

Keywords: long-term quality of life awake prone positioning acute respiratory distress syndrome